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Anatara Lifesciences to launch First-of-its-kind Decentralized Clinical Trial in Australia

30 September 2021 | News

ObvioHealth Partners with Anatara Lifesciences to offer clinical trial opportunities from patient's locations

Photo Credit: Freepik

Photo Credit: Freepik

ObvioHealth, a global Virtual Research Organization (VRO), is set to launch a first-of-its-kind clinical trial in Australia, using a combination of in-home data collection methods that will reduce, and in some cases, eliminate the need for follow-up visits to clinics.

The randomized, double-blind, placebo-controlled trial with Anatara Lifesciences will evaluate the safety and efficacy of a Gastrointestinal Re-Programming complementary medicine (GaRP) for participants with irritable bowel syndrome – diarrhea subtype (IBS-D).

Patients will report the severity of IBS-D symptoms and anticipated relief, quality of life, treatment adherence, and changes in health status through ObvioHealth's easy-to-use smartphone application. All data from the app flows into the ObvioHealth platform, where it is monitored in real-time, allowing the study team to quickly detect possible adverse events and issues with protocol adherence.

Clinical assessments will be performed during in-home visits by a study nurse to measure vitals and perform sample collection. Patients who wish to be assessed at a clinic will have access to a research center nearest them during the treatment period.

The unique study design and use of ObvioHealth's technology for virtual data capture remove barriers to recruitment, allowing enrollment to occur anywhere in Australia, even rural areas, and diversifying the study population.

ObvioHealth will be undertaking IBS-D clinical trial to demonstrate anticipated benefits following extensive pre-clinical work on the GaRP programme.

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